Medicare Payments for Stelara

Stelara (ustekinumab) is a high-cost prescription biologic approved to treat certain autoimmune diseases. Subcutaneous (under-the-skin) versions of Stelara are typically self-injected and covered under Medicare Part D. Prior to 2023, Medicare Part B also covered subcutaneous versions of Stelara when the injection was administered by a physician; however, Medicare Administrative Contractors now exclude Stelara injections under a policy designed to omit self-administered drugs from Part B coverage. The period during which Stelara was covered under Parts B and D provides a unique opportunity to examine how coverage determinations affect payments made by the Medicare program and costs for its enrollees. OIG will produce two work products related to Medicare payments and utilization trends for the subcutaneous versions of Stelara. The first product will focus on a cost comparison for enrollees with traditional fee-for-service Medicare Part B and standalone Part D drug plans. The second evaluation will focus on Medicare enrollee utilization patterns by setting—Stelara obtained in a physician's office (i.e., where injections would typically be administered by a health care provider) and Stelara obtained through a pharmacy (i.e., where injections would typically be self-administered at home).

Announced or Revised	Agency	Title	Component	Report Number(s)	Expected Issue Date (FY)
Revised	Centers for Medicare & Medicaid Services	Medicare Payments for Stelara	Office of Evaluation and Inspections	OEI-BL-19-00500; OEI-BL-19-00501	2024